TIMOLOL EYE DROPS 0.25%

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

Timoptol Eye Drops 0.25% / Timolol Eye Drops 0.25%
(timolol maleate)
This product is available using either of the above names but will be referred to as
Timoptol throughout the following leaflet. Please note this leaflet also contains
information about other strength (Timoptol Eye Drops 0.5%).
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Timoptol is and what it is used for
2. Before you use Timoptol
3. How to use Timoptol
4. Possible side effects
5. How to store Timoptol
6. Further information
1. What Timoptol is and what it is used for
Timoptol contains a substance called timolol which belongs to a group of
medicines called beta-blockers. Timolol lowers the pressure in your eye(s). It is
used to treat glaucoma, when the pressure in the eye is raised.
2. Before you use Timoptol
Do not use Timoptol if:
you are allergic (hypersensitive) to timolol, beta-blockers or any of the other
ingredients of Timoptol (see section 6 for Further Information)
you have now or have had in the past respiratory problems such as asthma,
severe chronic obstructive bronchitis (severe lung disease which may cause
wheeziness, difficulty in breathing and/or long-standing cough).
you have heart problems
slow heart beat
disorders of heart rhythm (irregular heart beats)
heart failure
− “cardiogenic shock” – a serious heart condition caused by very low blood
pressure, which may result in the following symptoms: dizziness and
lightheadedness, fast pulse rate, white skin, sweating, restlessness, loss of
consciousness.
If you are not sure whether you should use Timoptol talk to your doctor or
pharmacist.
Take special care with Timoptol
Before you use this medicine, tell your doctor if you have now or have had in the past
coronary heart disease (symptoms can include chest pain or tightness,
breathlessness or choking), heart failure,
low blood pressure
disturbances of heart rate such as slow heart beat.
breathing problems, asthma or chronic obstructive pulmonary disease.
poor blood circulation disease (such as Raynaud’s disease or Raynaud’s
syndrome).
diabetes as timolol may mask signs and symptoms of low blood sugar
overactivity of the thyroid gland as timolol may mask signs and symptoms.
allergies to any medicines.
you wear soft contact lenses. Your eye drops contain a preservative which can
be deposited on soft contact lenses. It is important that your lenses are
removed before using your eye drops and not put back into your eyes for 15
minutes.
Tell your doctor before you have an operation that you are using Timoptol as
timolol may change effects of some medicines used during anaesthesia.
If your eye becomes irritated or any new eye problems come on, talk to your
doctor straight away. Eye problems could include redness of the eye or swelling of
the eyelids (see Section 4: Possible Side Effects).
If you suspect that Timoptol is causing an allergic reaction or hypersensitivity (for
example, skin rash, or redness and itching of the eye), stop using Timoptol and
contact your doctor immediately.
Tell your doctor if:
you get an eye infection
you injure your eye or have an operation on it
your eye problems get worse or you get any new symptoms.
Use in children and adolescents
There is only very limited data available on the use of timolol in infants and
children. For example, in one small clinical study, timolol, the active ingredient in
Timoptol eye drops, has been studied in infants and children aged 12 days to 5
years, who have elevated pressure in the eye(s) or have been diagnosed with
glaucoma. For more information, talk to your doctor.
Timoptol should generally be used with caution in young patients. In newborns,
infants and younger children Timoptol should be used with extreme caution. If
coughing, wheezing, abnormal breathing or abnormal pauses in breathing (apnoea)
occur, the use of the medication should be stopped immediately. Contact your
doctor as soon as possible. A portable apnoea monitor may also be helpful.
Using other medicines
Timoptol can affect or be affected by other medicines you are using, including
other eye drops for the treatment of glaucoma. Tell your doctor if you are using or
intend to use medicines to lower blood pressure, heart medicine or medicines to
treat diabetes. Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including other eye drops or medicines
obtained without a prescription.

It is important to tell your doctor before using Timoptol if you are taking one or
more of the following medicines:
a calcium antagonist, such as nifedipine, verapamil or diltiazem, often used to
treat high blood pressure, angina, an abnormal heartbeat or Raynaud’s
syndrome
digoxin, a medicine used to relieve heart failure or treat abnormal heartbeat
medicines known as catecholamine-depleting agents, such as rauwolfia
alkaloids or reserpine, used for high blood pressure
medicines called pressor amines, such as adrenaline used to treat severe
allergic reaction
quinidine (used to treat heart conditions and some types of malaria).
antidepressants known as fluoxetine and paroxetine
clonidine, a medicine used to treat high blood pressure
other beta-blockers taken by mouth or used as eye drops, because they belong
to the same group of medicines as Timoptol and could have an additive effect.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine.
Use in pregnancy
Do not use Timoptol if you are pregnant unless your doctor considers it
necessary.
Use in breast-feeding
Do not use Timoptol if you are breast-feeding. Timolol may get into your milk. Ask
your doctor for advice before taking any medicine during breast-feeding.
Driving and using machines
There are possible side effects associated with Timoptol, such as dizziness,
tiredness and changes in your eyesight, such as blurred vision, drooping of the
upper eyelid (making the eye stay half closed), double vision which may affect
your ability to drive and/or operate machinery. Do not drive and/or operate
machinery until you feel well and your vision is clear.
3. How to use Timoptol
Always use Timoptol eye drops solution exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure. The doctor will
decide how many drops you should take each day and how long you should use
them.
The usual dose is one drop in the affected eye(s) twice each day:
one in the morning
one in the evening.
Do not change your usual dose without talking to your doctor.
Do not allow the tip of the container to touch the eye or areas around the eye. It
may become contaminated with bacteria that can cause eye infection leading to
serious damage of the eye, even loss of vision. To avoid possible contamination
of the container, keep the tip of the container away from contact with any surface.
Instructions for use.
It is recommended that you wash your hands before putting in your eye drops.
1. Before using the medication for the first time, be sure the Safety Strip on the
front of the bottle is unbroken. A gap between the bottle and the cap is normal
for an unopened bottle
Opening Arrows ►
Safety Strip ►

2. Tear off the safety strip to break the seal.

Gap ►
Finger Push Area ►

3. To open the bottle, unscrew the cap by turning as indicated by the arrows on
top of the cap. Do not pull the cap directly up and away from the bottle. Pulling
the cap directly up will prevent your dispenser from operating properly.

Finger Push Area ►

4. Tilt your head back and pull your lower eyelid down slightly to form a pocket
between your eyelid and your eye.

5. Invert the bottle, and press lightly with your thumb or first finger over the
‘Finger-Push Area’ as shown until a single drop is dispensed into your eye, as
directed by your doctor.
◄Finger Push Area

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.

6. After using Timoptol, press a finger into the corner of your eye, by the nose for
2 minutes. This helps to stop timolol getting into the rest of your body.
Ophthalmic medications, if handled improperly, can become contaminated by
common bacteria known to cause infections. Serious damage to the eye and
subsequent loss of vision may result from using contaminated ophthalmic
medications. If you think your medication may be contaminated, or if you
develop an eye infection, contact your doctor immediately concerning
continued use of this bottle.
7. If drop dispensing is difficult after opening for the first time, replace the cap on
the bottle and tighten (do not overtighten) and then remove by turning the cap
in the opposite direction as indicated by the arrows on top of the cap.
8. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.
9. Replace the cap by turning until it is firmly touching the bottle. The arrow on
the left side of the cap must be aligned with the arrow on the left side of the
bottle label for proper closure. Do not overtighten or you may damage the
bottle and cap.
10. The dispenser tip is designed to provide a single drop; therefore do NOT
enlarge the hole of the dispenser tip.
11. After you have used all doses there will be some Timoptol left in the bottle.
You should not be concerned since an extra amount of Timoptol has been
added and you will get the full amount of Timoptol that your doctor has
prescribed. Do not attempt to remove the excess medicine from the bottle.
Use in children and adolescents
Before you or your child starts to take Timoptol, your doctor or your child’s doctor
will have carried out a detailed medical examination and decided whether or not
this medicine is suitable. You or your child, especially a newborn, should be
closely monitored for one to two hours after the first dose and carefully monitored
for any signs of side effects until surgery is carried out.
Method of administration:
One drop only of Timoptol should be instilled into the affected eye(s) each time.
Follow the “Instructions for Use” above when administering the eye drops. After
instillation keep the eyes closed for as long as possible (e.g. 3 – 5 minutes) and
apply pressure to the corner of the eye closest to the nose to prevent the eye
drops spreading throughout the body.
Duration of treatment:
Your doctor or your child’s doctor will decide for how long the eye drops will be
needed.
If you use more Timoptol than you should
If you put too many drops in your eye or swallow any of the drops, you may:
have a headache
feel dizzy or light-headed
have difficulty breathing
chest pain
feel that your heart rate has slowed down.
If this happens, contact your doctor immediately.
If you forget to use Timoptol
It is important to take Timoptol as prescribed by your doctor.
If you miss a dose, use the drops as soon as possible.
If it is almost time for the next dose, skip the missed dose and take the next
dose at the usual time.
Do not take a double dose to make up for the forgotten dose.
If you stop using Timoptol
If you want to stop using this medicine talk to your doctor first. If you have any
further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Timoptol can cause side effects, although not everybody gets them.
You can usually carry on taking the drops, unless the effects are serious. If you’re
worried, talk to a doctor or pharmacist. Do not stop using Timoptol without
speaking to your doctor.
Like other medicines applied into eyes, timolol is absorbed into the blood. This
may cause similar side effects as seen with intravenous and/or oral beta-blocking
agents. Incidence of side effects after topical ophthalmic administration is lower
than when medicines are, for example taken by mouth or injected. Listed side
effects include reactions seen within the class of beta-blockers when used for
treating eye conditions.
If you develop allergic reactions including swelling beneath the skin that can occur
in areas such as the face and limbs, and can obstruct the airway which may cause
difficulty swallowing or breathing, hives or itchy rash, localized and generalized
rash, itchiness, severe sudden life-threatening allergic reaction, stop taking your
eyes drops and seek medical attention immediately.
Low blood glucose levels.
Difficulty sleeping (insomnia), depression, nightmares, memory loss.
Fainting, stroke, reduced blood supply to the brain, increases in signs and
symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations
like tingling or pins and needles, and headache.
Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing,
redness), inflammation of the eyelid, inflammation in the cornea, blurred vision
and detachment of the layer below the retina that contains blood vessels following
filtration surgery which may cause visual disturbances, decreased corneal
sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball),
drooping of the upper eyelid (making the eye stay half closed), double vision,
sensitivity to light, discharge from the eye, pain in the eye.
Ringing sound in the ears.

Slow heart rate, chest pain, palpitations, oedema (fluid build up), changes in the
rhythm or speed of the heartbeat, congestive heart failure (heart disease with
shortness of breath and swelling of the feet and legs due to fluid build up), a type
of heart rhythm disorder, heart attack, heart failure.
Low blood pressure, fainting, interference with the blood supply to the brain which
may lead to a stroke, Raynaud’s phenomenon, cold hands and feet, limping
because there is a reduced blood supply to your legs.
Constriction of the airways in the lungs (predominantly in patients with pre-existing
disease), difficulty breathing, shortness of breath, wheezing, cough.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain,
vomiting.
Sexual dysfunction, decreased sex drive, decreased libido. In men a condition
which effects your penis called Peyronie’s disease. The signs may be abnormal
curve, pain or hardening of the tissue of your penis.
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or
worsening of psoriasis, skin rash, itching.
Muscle weakness/tiredness, muscle pain not caused by exercise. A condition
called lupus (systemic lupus erythematosus).
Ask your doctor or pharmacist for more information about the side effects. Both
have a more complete list of side effects.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of
this medicine
5. How to store Timoptol
Keep out of the sight and reach of children
Store the bottle below 25°C and protect from light.
Do not use the eye drops if the tamper-evident seal on the bottle is broken.
The eye drops should not be used after the expiry date printed on both the
carton and the label on the bottle.
Any solution remaining 28 days after first opening should be discarded or taken
to your pharmacist for safe disposal.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
If the product shows any signs of deterioration, consult your doctor or
pharmacist.
6. Further information
Timoptol contains timolol maleate equivalent to 0.25% w/v Timolol.
Timoptol also contains the following:
sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate,
sodium hydroxide, benzalkonium chloride and water for injections.
Timoptol is packaged in cartons containing one 5ml bottle and are ONLY for use
in the eyes.
POM

PL No: 17805/0066

This product is manufactured by Merck Sharp & Dohme B.V., P.B. 581Waarderweg 39, NL-2003-PC Haarlem and procured from within the EU by the PL
holder: Delta Pharma (Europe) Ltd, 1 Colonial Way, P.O. Box 233, North Watford,
Herts WD24 4EW and repackaged by O.P.D. Laboratories Ltd, Watford Herts
WD2 4PR.
Leaflet revision and issue date (Ref.) 08.05.2014.
Timoptol is a registered Trade Mark of Merck & Co. Inc, New Jersey, U.S.A.
To request a copy of this leaflet in Braille, large print or audio please call 01923
332 796.
This leaflet gives the most important patient information about Timoptol. If you
have any questions after you have read it, ask your doctor or pharmacist who will
give you further information.
Further information about glaucoma is available from:
International Glaucoma Association (IGA)
15A Highpoint Business Village
Henwood, Ashford
Kent, TN24 8DH
Tel: +44 (0) 1233 648170
E-mail: info@iga.org.uk
Registered Charity number 274681.
Alternatively, if you or someone you know has problems with their vision, and you
require further advice or information, please contact:
For the UK: the Royal National Institute for the Blind (RNIB) Helpline on 0303 123
9999, Monday to Friday 8.45am to 6pm and Saturday 9am to 4pm.
For Ireland: National Council for the Blind of Ireland, Whitworth Road,
Drumcondra, Dublin 9. Tel: 01 8307033 or Fax: 01 8307787 charity registration
number: CHY 4626.

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